Corgard

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Corgard

WARNINGS

Cardiac Failure

Sympathetic stimulation may be a vital component supporting circulatory function
in patients with congestive heart failure, and its inhibition by beta-blockade
may precipitate more severe failure. Although beta-blockers should be avoided
in overt congestive heart failure, if necessary, they can be used with caution
in patients with a history of failure who are well-compensated, usually with
digitalis and diuretics. Beta-adrenergic blocking agents do not abolish the
inotropic action of digitalis on heart muscle.

IN PATIENTS WITHOUT A HISTORY OF HEART FAILURE, continued use of beta-blockers
can, in some cases, lead to cardiac failure. Therefore, at the first sign or
symptom of heart failure, the patient should be digitalized and/or treated with
diuretics, and the response observed closely, or nadolol should be discontinued
(gradually, if possible).

Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal—Hypersensitivity
to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have
occurred after abrupt discontinuation of such therapy. When discontinuing chronically
administered nadolol, particularly in patients with ischemic heart disease,
the dosage should be gradually reduced over a period of one to two weeks and
the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, nadolol administration should be reinstituted
promptly, at least temporarily, and other measures appropriate for the management
of unstable angina should be taken. Patients should be warned against interruption
or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue
nadolol therapy abruptly even in patients treated only for hypertension.

Nonallergic Bronchospasm (e.g., chronic bronchitis, emphysema)

PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS.
Nadolol should be administered with caution since it may block bronchodilation
produced by endogenous or exogenous catecholamine stimulation of beta2
receptors.

Major Surgery

Chronically administered beta-blocking therapy should not be routinely withdrawn
prior to major surgery; however, the impaired ability of the heart to respond
to reflex adrenergic stimuli may augment the risks of general anesthesia and
surgical procedures.

Diabetes and Hypoglycemia

Beta-adrenergic blockade may prevent the appearance of premonitory signs and
symptoms (e.g., tachycardia and blood pressure changes) of acute hypoglycemia.
This is especially important with labile diabetics. Beta-blockade also reduces
the release of insulin in response to hyperglycemia; therefore, it may be necessary
to adjust the dose of antidiabetic drugs.

PRECAUTIONS

Impaired Renal Function

Carcinogenesis, Mutagenesis, Impairment of Fertility

In chronic oral toxicologic studies (one to two years) in mice, rats, and dogs,
nadolol did not produce any significant toxic effects. In two-year oral carcinogenic
studies in rats and mice, nadolol did not produce any neoplastic, preneoplastic,
or non-neoplastic pathologic lesions. In fertility and general reproductive
performance studies in rats, nadolol caused no adverse effects.

Pregnancy

Category C

In animal reproduction studies with nadolol, evidence of embryo- and fetotoxicity
was found in rabbits, but not in rats or hamsters, at doses 5 to 10 times greater
(on a mg/kg basis) than the maximum indicated human dose. No teratogenic potential
was observed in any of these species.

There are no adequate and well-controlled studies in pregnant women. Nadolol
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus. Neonates whose mothers are receiving nadolol at
parturition have exhibited bradycardia, hypoglycemia, and associated symptoms.

Nursing Mothers

Nadolol is excreted in human milk. Because of the potential for adverse effects
in nursing infants, a decision should be made whether to discontinue nursing
or to discontinue therapy taking into account the importance of CORGARD (nadolol)
to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Last reviewed on RxList: 7/25/2013
This monograph has been modified to include the generic and brand name in many instances.